Descrizione Clinica
Fever Paracetamol mv 20cpr 500mg Marco Viti
PARACETAM MARCO VITI 500 MG COMPRESENT
active ingredients
Each tablet contains: active ingredient: paracetamol 500 mg. For the full list of excipients, see paragraph 6.1.Excellent
Magnesium stearate, corn starch, povidone.Therapeutic indications
How antipyretic: symptomatic treatment of feverish affections such as influenza, hexanthomatic diseases, acute affections of the respiratory tract, etc. As analgesic: cephales, neuralgies, myalgies and other painful manifestations of medium-sized, of various origin.Contraindications
Hypersensitivity to paracetamol or any of the excipients listed in paragraph 6.1.Dosage
For children it is essential to respect the defined dosage according to their body weight, and therefore to choose the suitable formulation. Approximate ages according to body weight are indicated as information. In adults, the maximum oral posology is 3000 mg of paracetamol per day (see paragraph 4.9). The doctor must assess the need for treatments for over 3 consecutive days. The Posological scheme of Paracetamolo Marco Viti in relation to the weight is as follows: Children weighing between 26 and 40 kg (approximately between 8 and 13 years): 1 tablet at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. Children weighing between 41 and 50 kg (approximately between 12 and 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. Children weighing more than 50 kg (approximately over 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. Adults: 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. In case of severe pain or high fever, 2 tablets of 500 mg to be repeated if necessary after not less than 4 hours. Renal insufficiency In case of severe renal failure (creatiny clearance less than 10 ml/min), the interval between administrations must be at least 8 hours.Conservation
This medicine does not require any special condition of conservation.Warnings
In rare cases of allergic reactions, administration must be suspended and appropriate treatment must be established. Use carefully in case of chronic alcoholism, excessive alcohol intake (3 or more alcoholic beverages per day), anorexia, bulimia or cachesia, chronic malnutrition (low reserves of liver glutathione) dehydration, hypovolemia. Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe liver failure (Child-Pugh > 9), severe liver failure, acute hepatitis, in concomitant treatment with drugs that alter liver function, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia. High or prolonged doses of the product may cause serious alterations to the kidney and blood, so the administration in the subjects with kidney failure should be carried out only if effectively necessary and under direct medical control. In case of protracted use it is advisable to monitor the liver and renal function and the blood crasis. It is recommended caution if the paracetamol is administered in conjunction with flucloxacillin due to increased risk of metabolic acidosis with high anionic gap (HAGMA), in particular in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as in those using the daily maximum doses of paracetamine. Careful monitoring is recommended, including the measurement of 5-oxoproline urinary. During treatment with paracetamol before taking any other medication check that does not contain the same active ingredient, since if the paracetamol is taken in high doses severe adverse reactions may occur. Invite the patient to contact the doctor before associating any other medication. See also paragraph 4.5.Interactions
The oral absorption of the paracetamol depends on the speed of gastric emptying. Therefore, the concomitant administration of drugs that slow (e.g. anti-linergics, opioids) or increase (e.g. procinetics) the speed of gastric emptying can determine respectively a decrease or increase of the bioavailability of the product. Concurrent administration of cholasteramine reduces the absorption of paracetamol. Contemporary intake of paracetamol and chloramphenicol can lead to an increase in the half-life of chloramphenicol, with the risk of increasing its toxicity. Concurrent use of paracetamol with oral anticoagulants can induce slight variations in INR values. In these cases a more frequent monitoring of INR values should be conducted during concurrent use and after its interruption. Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monoxygenases or in case of exposure to substances that may have such an effect (e.g. reampycin, cimetidine, antiepileptics such as glutetimmide, phenobarbital, carbamazepine). The same applies in cases of ethylism and in patients treated with zidovudine. Paracetamol administration may interfere with the determination of urine (by the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase). Be careful when paracetamol is used in conjunction with flucloxacillin since concurrent intake was associated with metabolic acidosis with high anionic gap, especially in patients with risk factors (see paragraph 4.4).Effects
Below are the undesirable effects of the paracetamol organized according to the systemic and organic classification MedRA. No sufficient data is available to determine the frequency of the individual effects listed.| Emolinfopoietic system pathologies | Trombocytopenia, leucopenia, anemia, agranulocytosis |
| Immune system disorders | Hypersensitivity reactions (orticaria, larynx edema, angioedema, anaphylactic shock) |
| Diseases of the nervous system | Vertigo |
| Gastrointestinal diseases | Gastrointestinal reaction |
| Hepatobiliary diseases | Abnormal liver function, hepatitis |
| Pathologies of skin and subcutaneous tissue | Multiform erythema, Stevens Johnson syndrome, epidermal necrolysis, skin rash |
| Kidney and urinary disorders | Acute renal insufficiency, interstitial nephritis, hematuria, anuria |
Overdosing
There is a risk of intoxication, especially in patients with liver disease, in case of chronic alcoholism, in patients suffering from chronic malnutrition, and in patients receiving enzyme inductors. In these cases overdose can be fatal. Synonyms In case of accidental intake of very high doses of paracetamol, acute intoxication manifests with anorexia, nausea and vomiting followed by deep decay of general conditions; such symptoms usually appear within the first 24 hours. In case of overdose, paracetamol can cause liver cytolysis that can evolve towards massive and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy, which can lead to coma and death. Simultaneously, an increase in levels of hepatic transaminasis, lactic-dedrogenase, and bilirubinemia are observed, and a reduction in levels of protrombin, which can occur in 12 to 48 hours after ingestion. Treatment The measures to be taken consist of early gastric emptying and hospitalisation for the appropriate treatment, through the administration, as early as possible, of N-acetylcysteine as an antidote: the dosage is 150 mg/kg e.v. in glucosated solution in 15 minutes, then 50 mg/kg in the next 4 hours and 100 mg/kg in the following 16 hours, for a total of 300 mg/kg in 20 hours.Despite clinical studies in pregnant or breastfeeding patients, no particular contraindications to the use of paracetamol or undesirable effects to the mother or child, it is recommended to administer the product only in cases of actual need and under the direct control of the doctor. A large amount of data on pregnant women do not indicate neither malformative toxicity, nor fetal/neonatal toxicity.
Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results.If clinically necessary
, the paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for as short as possible and with the lowest frequency possible.Source: Farmadati
